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Prospective, Randomized, Multicentric, Comparative Trial of Two Devices in Surgical Treatment of Post-radical Prostatectomy Stress Urinary Incontinence: Periurethral Pro-ACTTM Balloons and AdvanceTM Retrourethral Male Sling


N/A
18 Years
N/A
Open (Enrolling)
Male
Stress Urinary Incontinence

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Trial Information

Prospective, Randomized, Multicentric, Comparative Trial of Two Devices in Surgical Treatment of Post-radical Prostatectomy Stress Urinary Incontinence: Periurethral Pro-ACTTM Balloons and AdvanceTM Retrourethral Male Sling


Background: Stress urinary incontinence (SUI) is a common adverse event of radical
prostatectomy (RP) for localized prostate cancer and can dramatically impact quality of
life. Management of SUI after RP is based on conservative measures and pelvic floor muscle
training. In case of failure of this first line therapy, surgical treatment is required. In
recent years, periurethral Pro-ACT balloons and retrourethral Advance male sling have been
proven to be efficient to manage SUI after RP in case of mild to moderate symptoms. Pro-ACT
balloons are placed under general anesthesia via a perineal approach, laterally to the
membranous urethra under the bladder neck. This device results in an external compression of
the urethra. Further adjustment of the compression is possible under local anesthesia since
the balloons are linked to a subcutaneous titanium port. Advance male sling is placed under
general anesthesia via a perineal approach, by transobturator route, and results in a
suspension of the membranous urethra relocating the bladder neck. If multiple reports have
claimed for the efficacy of these two devices, they have never been compared in a
prospective comparative trial. Our aims were to compare the efficacy of the two devices and
provide data about their cost effectiveness.

Hypothesis: The study is based on the superiority hypothesis that Advance male slings is
more efficacious than Pro-ACT balloons at one year follow-up.

Objectives:

The primary objective of this study is to compare the efficacy of the Advance retrourethral
male sling and periurethral Pro-ACT balloons for post-prostatectomy stress urinary
incontinence (SUI) management.

The secondary objectives of this work are:

- Comprehensive medical evaluation of these two emerging devices in terms of efficiency
using the usual criteria in the field of urinary incontinence

- Complete evaluation of the side effects of the two techniques

- Evaluation of the quality of life

- Cost-effectiveness study of the device (Total cost over one year of each of the two
techniques, differential cost-effectiveness ratio (cost adjusted by QALY), differential
cost-effectiveness ratio in terms adjusted to success rate, recommendations that can be
made for assessing the potential coverage by the French healthcare system

Population: The study concerns patients presenting SUI following radical prostatectomy for
prostate cancer. Patients must be older than 18, without cancer recurrence, and must
present pure SUI on urodynamics (without detrusor overactivity), and mild to moderate
incontinence (24hour pad-test < 300g). Every patient showing urethral stricture at
preoperative cystoscopy is excluded from the study.

Study design: This is a prospective, randomized, multicentric (9 tertiary reference
centers), comparative trial of the two devices (with a superiority hypothesis). The study
begins with a 12 months inclusion period. The total number of subjects required is 240. At
the end of the inclusion process, a randomization in two arms is carried out. Follow-up
consists in 4 visits at 1, 3, 6 and 12 months, with data collection (pad use, uroflowmetry,
quality of life validated questionnaires ICIQ-SF and EQ-5D, 24-hr pad test, patient
satisfaction with PGI-I and report of any secondary effect). Statistical evaluation is
carried out at the end of the follow-up, in intent to treat.

Medical evaluation:

The main criterion of the study is failure of the treatment, defined by reduction of less
than 50% of incontinence on 24-hr pad test, explantation of the device or implantation of a
new surgical device for SUI management in the year after operation.

Secondary criteria are focused on efficacy and tolerance and evaluated during follow-up at
1, 3, 6 and 12 months on the following criteria:

- pad usage per day

- quantitative reduction of the 24hr-pad test

- complications (infection, erosion, hematoma, acute urinary retention)

- number of re-interventions or re-admissions during follow-up

- quality of life measured by the ICIQ-SF questionnaire

- patient satisfaction by the PGI-I questionnaire The statistical evaluation on the main
criterion will be carried out by the chi-square test. Variables with a known predictive
value on efficiency (radiation therapy, severity of incontinence) will be studied by
logistic regression then multivariate analysis. The results will be adjusted on the
centers (multicentric study). The quantitative variables will be compared by
Mann-Whitney test.

Economic evaluation: The economic evaluation will be carried out according to the following
manner:

- A study of the total cost over one year of each device, based on the data collected
during the clinical trial and including all the events that required medical care
(visits, complications, reinterventions, readmissions), but also the cost of pads (not
supported by healthcare system, and only supported by the patient).

- From this study led on cost and of the collection of quality of life data, the cost of
each device will be adjusted to quality of life (QALY evaluation)

- A cost effectiveness study will also be lead, by adjusting cost to success rate of each
technique

- Proposals will be made to state at which level the two devices should be covered by the
healthcare system.


Inclusion Criteria:



- Age > 18 years

- Patient presenting mild to moderate stress urinary incontinence (20g < 72 hours
pad-test < 300g) following radical prostatectomy more than 1 year ago.

- Patient capable of roaming, independent and capable of using toilet without any
trouble.

- Patients able to answer to questionnaire and communicate in French

- Informed consent

- Patients with social security

Exclusion Criteria:

- Uncontrolled prostatic adenocarcinoma or PSA > 1 ng/ml

- Maximum urinary flow rate < 15 ml/sec

- Postvoid residual volume > 150 ml

- Urinated volume in 24h > 3000 ml

- Uninhibited detrusor contractions associated with leakage during the preoperative
urodynamic assessment (realized under anticholinergic if the patient is usually under
this medication)

- Severe incontinence (Pad test > 300g/24h)

- History of artificial urinary sphincter

- Known neurologic bladder dysfunction

- History of neurological disease which can interfere with the urinary symptoms

- Presence of a urethral stenosis or of an anastomotic stricture during the
preoperative endoscopy.

- Previous treatment with pelvic radiation therapy in 6 months before inclusion

- Uncontrolled urinary tract infection

- Patients affected by an infiltrative bladder tumour

- Patients with bladder stones

- Severe constitutional hemorrhagic disease or haemophilia

- Deep depression of immune system

- Severe renal impairment or obstructive pathology of the upper urinary tract with
severe renal impairment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

failure of the treatment, defined by reduction of less than 50% of incontinence on 24-hr pad test, explantation of the device or implantation of a new surgical device for SUI management in the year after operation

Outcome Time Frame:

12 months after surgical treatment

Safety Issue:

No

Principal Investigator

François Haab

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

P100143

NCT ID:

NCT01500603

Start Date:

November 2012

Completion Date:

November 2014

Related Keywords:

  • Stress Urinary Incontinence
  • post-radical prostatectomy
  • stress urinary incontinence
  • periurethral Pro-ACT balloons
  • Advance retrourethral male sling
  • Urinary Incontinence
  • Urinary Incontinence, Stress

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